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Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia — Flexdose  

Fibromyalgia Clinical Trial

Official title:
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Clinical Trial Summary

A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01226667
Study type Interventional
Source Osteoporosis Medical Center, Beverly Hills, CA
Contact
Status Completed
Phase Phase 4
Start date July 2010
Completion date July 2012
View Details
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